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Dietary ModificationBeefNCT02675348

Beef Protein Supplementation in Endurance Athletes

A study testing Dietary Supplement: Beef Protein, Dietary Supplement: whey Protein and Dietary Supplement: CHO in people with Dietary Modification, run by University of Greenwich at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this project is to investigate the potential benefits of combining a new protein beef hydrolysates extract with a regular endurance training programme on (a) body composition (b) performance (c) muscle structure (d) blood markers of health in athletes. Read more about this study

Who is it for?
Ages 30 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Dietary Modification
What is being tested?
Dietary Supplement: Beef Protein, Dietary Supplement: whey Protein and Dietary Supplement: CHO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2016to Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • regularly trained endurance athletes,
  • aged 30 to 60 years old,
  • minimum 2 years of experience,
  • volunteers,

Who cannot join

  • any musculoskeletal injuries, metabolic conditions, or diseases;
  • use of medications, smoking, and nutritional supplements known to affect physical performance, muscle damage or recovery process (e.g., creatine, whey protein, and amino acids) within 6 weeks prior to the start of the study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Department of Life and Sports Science

    Chatham, Kent, ME4 4TB

Other trials in United Kingdom

About this study

Official title: Effects of Meat Protein Administration on Body Composition, Strength, Muscle Structure, Immunological and Haematological Markers in Endurance Athletes

The aim of this project is to investigate the potential benefits of combining a new protein beef hydrolysates extract with a regular endurance training programme on (a) body composition (b) performance (c) muscle structure (d) blood markers of health in athletes. As a second objective the investigators will analyse potential differences obtained from the ingestion of the new hydrolysates beef protein extract compared to the ingestion of others commercially available protein sources such as whey and non protein only carbohydrate contrast nutrients.

Read the detailed description

This investigation involves a 10 weeks randomised, balanced, double blind parallel group between-subjects design aimed to analyse the effects of combining exercise and a post exercise nutrition strategy (hydrolysates beef protein, whey protein or a isocaloric only carbohydrate placebo) on training outcomes, body composition and blood markers after a period of regular training and feeding intervention. Participants will be divided in three-treatment groups 1) Hydrolysed meat-protein (Beef); 2) Whey (Whey) and 3) non-protein iso-energetic placebo (CHO).

Once considered eligible for the study, and after an initial familiarisation period and baseline tests, participants will be randomly assigned to one of the intervention groups: Beef; Whey and CHO. Each group will follow a 10-week periodised endurance training intervention combined with one of the three specific supplementation treatments (Beef, Whey or CHO). Measurements of blood, body composition, muscle structure and endurance performance will be determined before and after the training intervention.

Once informed consent and health history have been obtained, after the baseline Assessment (t1), participants will divided into three similar profile groups, matched by body mass, age, sex and performance (Vo2max). 1) The Beef protein group (Beef n=12) that will take 20g of hydrolysates beef protein powder and 250 ml of water 2) The whey group (n=12) will take 20 g of whey intact isolate powder mixed with 250 ml of water 3) the contrast group (CHO n=12) that will take an iso-energetic non-protein, only carbohydrate (20 f of maltodextrin plus 250 ml of water) contrast.

Participants: Thirty six participants, recruited from Kent, Medway University Campus, will take part in the project. After being informed of all risk, discomforts, and benefits involved, participants will sign a written informed consent regarding their participation.

Intervention Familiarization period: Participants will undertake 1 sessions of familiarisation with the testing procedure. A qualified conditioning coach will control and assists participants in order to guarantee a correct understanding of the assessment procedure (Body composition, vo2max test, muscle thickness, etc). All participants will be instructed about the appropriate use of the Rate of Perceived Exertion (6-20) Borg scale and the heart rate monitor to control the load and training intensity during test and training.

Endurance Training: Participants will commit to follow a polarised triphasic endurance-training model. This model contains three intensity zones calculated as low intensity [≥ the first ventilatory threshold (VT1), ~ 70% HRmax]; moderate intensity [between VT1 and respiratory compensation point or ventilatory threshold 2 (VT2), >70 < 90% HRmax]; and high intensity [>VT2, 90% HRmax] (Esteve-Lanao et al., 2007). Participants will train 4 to 6 times per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity.

Supplementation protocol: Training days: Immediately (<10 min) after com Non-training days: before breakfast.

Supplements and placebo will be provided in powder form and should be mixed with 250 ml of plain water at the moment of consumption. Supplements and placebo will looks and tastes identical.

Thus, a total of one 20g doses will be administered on daily bases. Participants should ingest a total of 70 doses for a total of 10 weeks of study intervention.

Supplement will be provided in 14 days based by a blind researcher after Participants should return back the empty bag of the supplement/placebo consumed during the previous 14 days period.

Being tested
Dietary Supplement: Beef Protein, Dietary Supplement: whey Protein, Dietary Supplement: CHO

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary Supplement: Beef ProteinDietary supplement

    Also called 100% all beef

    Participants will combine a 10-week periodized and controlled endurance programme with the ingestion of beef protein supplement after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes

  • Dietary Supplement: whey ProteinDietary supplement

    Also called Whey protein powder

    Participants will combine a 10-week periodized and controlled endurance programme with the ingestion of whey protein supplement after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes

  • Dietary Supplement: CHODietary supplement

    Also called maltodextrin

    Participants will combine a 10-week periodized and controlled endurance programme with the ingestion of maltdextrin after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes

Study groups in NCT02675348
Study groupRoleWhat they receive
Dietary Supplement: Beef ProteinExperimentalAll the groups will perform a similar endurance training involved 4 to 6 workout per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity. Training session will last from 45 min to a maximum of 120 min. Intervention will last for 10 weeks. Participants will ingest 20g of beef protein powder mixed with 250ml of water at post workout (training days) or before breakfast (non training days).
Receives: Dietary Supplement: Dietary Supplement: Beef Protein
Dietary Supplement: Whey ProteinExperimentalAll the groups will perform a similar endurance training involved 4 to 6 workout per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity. Training session will last from 45 min to a maximum of 120 min. Intervention will last for 10 weeks. Participants will ingest 20g of whey protein powder mixed with 250ml of water at post workout (training days) or before breakfast (non training days).
Receives: Dietary Supplement: Dietary Supplement: whey Protein
Dietary Supplement: CHOActive comparatorAll the groups will perform a similar endurance training involved 4 to 6 workout per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity. Training session will last from 45 min to a maximum of 120 min. Intervention will last for 10 weeks. Participants will ingest 20g of maltodextrin powder mixed with 250ml of water at post workout (training days) or before breakfast (non training days).
Receives: Dietary Supplement: Dietary Supplement: CHO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body composition

    Fat-Free mass

    Measured: 10 weeks

  2. Body composition

    Fat mass

    Measured: 10 Weeks

  3. Muscular thickness

    vastus medialis thickness

    Measured: 10 weeks

  4. Endurance Performance

    Vo2max

    Measured: 10 weeks

  5. Endurance Performance

    Ventilatory threshold 2

    Measured: 10 Weeks

  6. Blood Markers

    haemoglobin

    Measured: 10 weeks

  7. Blood Markers

    red blood cell

    Measured: 10 weeks

  8. Blood Markers

    haematocrit

    Measured: 10 weeks

  9. Blood Markers

    transferrin

    Measured: 10 weeks

Secondary outcomes (3)
  1. Immunology markers

    neutrophils

    Measured: 10 weeks

  2. Immunology markers

    lymphocyte

    Measured: 10 weeks

  3. Immunology markers

    monocytes

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2016
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02675348
Sponsor's protocol ID
fES-uREC-15-1 3 02
Acronym
Beef
Status last verified
May 2017
First submitted
2 Feb 2016
Last updated
9 May 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Supplement: Beef Protein, Dietary Supplement: whey Protein and Dietary Supplement: CHO in people with Dietary Modification, run by University of Greenwich at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body composition (time frame: 10 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.

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